Bone anchor-insertion tool and surgical method employing same

ABSTRACT

An anchor-insertion tool for securing an anchor having a suture extending therefrom to a structure within a patient&#39;s body is provided. The anchor-insertion tool comprises an elongate shaft having distal and proximal ends, an anchor-receiving tip at the distal end, at least one groove extending from the tip at least partially along the length of the shaft, and at least one depression extending about the circumference of the shaft and intersecting the groove. A loaded anchor-insertion tool is provided, along with a surgical method for employing the anchor-insertion tool. A surgical template and suture retriever are also provided.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of application Ser. No.08/490,281, which was filed on Jun. 14, 1995 now U.S. Pat. No.5,697,931.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed towards a bone anchor-insertion tool,a suture retriever, a surgical template and a surgical method employingthe same, all of which are particularly suited for a laparoscopicurethropexy procedure for the correction of female stress urinaryincontinence. More particularly, the present invention providesapparatus and methods for performing the urethropexy throughlaparoscopic techniques, thereby greatly reducing the duration,discomfort, and recovery period of such surgeries.

2. Description of Related Art

Female stress urinary incontinence (SUI), defined as the unintentionalloss of urine, can be a socially unacceptable problem for many women.Most often, the incontinence occurs during coughing, sneezing, orphysical activity in women afflicted with this problem. While effectivesurgical treatment for this condition has existed for nearly 50 years,the procedures typically involve major abdominal surgery withaccompanying post-operative limitations lasting six to eight weeks.Because of the nature of these surgical procedures, many women simplyresort to diaper-like incontinence pads, or simply avoid any activitieswhich result in the unintentional loss of urine.

In the normal resting state, the external pressure exerted on thecollapsible urethra by the surrounding musculature is greater than thepressure exerted on the bladder, and therefore continence is maintained.During moments of coughing, sneezing, or physical activities, greaterpressure will be exerted on the dome of a filled bladder. In women notafflicted with stress incontinence, a corresponding increase in theexternal pressure on the urethra acts to prevent the unwanted loss ofurine from the bladder. Sufferers of SUI, however, aren't so fortunate.

Stress incontinence is generally caused by two etiologies: a spasticdetrusor muscle; or a loss of support of the periurethral tissue at theurethra-vesicular junction ("UVJ"--the region where the urethra entersthe bladder). When the latter situation occurs, the UVJ will sag intothe vagina, thereby reducing the pressure which can be exerted on theurethra during moments of stress. Diagnosis of any sagging of the UVJcan be easily determined by inserting the tip of a cotton swab into theurethra until it reaches the UVJ. The patient is then asked to bear downas if urinating, and loss of the UVJ support is readily identified bythe upward movement of the wooden end of the cotton swab. In this test,the external urethral meatus acts as a fulcrum for the tip of the swab,and the elevation of the opposite end indicates the downward descent ofthe UVJ. U.S. Pat. No. 4,072,144 provides an alternative device whichmay be utilized to readily measure the angle of the UVJ in a similarmanner.

The first urethropexy procedure for eliminating SUI caused by a saggingurethra was developed in 1948 by Drs. Marshall, Marchetti, and Krantz,and generally involves the fixation of the periurethral tissue at theUVJ on either side of the urethra (MMK procedure). Fixation in the MMKprocedure, also known as urethropexy or abdominal culposuspension, isaccomplished by suturing the periurethral fascia at the UVJ on eitherside of the urethra to the periosteum of the pubic bone. The procedureessentially alters the angular relationship between the urethra andbladder by elevating the UVJ, and therefore preventing the sagging ofthe UVJ when downward pressure is applied to the region by variousstresses.

The MMK procedure has been perfected over the years, however theessential principles have remained the same. In 1955 Burch developed thetechnique of affixing the periurethral fascia bilaterally to Cooper'sligament, thereby resulting in a technically easier procedure because ofthe previous difficulties in passing a needle through the periosteum ofthe pubic bone. Although the Burch procedure has been performedlaparoscopically, the five-year failure rate for the open Burchprocedure is approximately 60%. A laparoscopic Burch procedure is evenmore problematic since it is extremely difficult and time-consuming totie sutures laparoscopically.

Alternatively, urological procedures such as that of Stamey, Raz andPeyerra have been developed, however these are typically blindprocedures which require the passing of long needles through the rectusfascia to the periurethral fascia utilizing a cystoscope. Although theseurological procedures avoid the 10-centimeter midline or Pfannenstielincision and its required three-day or longer hospital stay, thegynecological procedures of MMK, Burch and others have proven to be themost effective. In fact, the scarring of the urethra and interiorbladder as well as the scarring of the periurethral tissues, aids infixation of all of the involved tissues during the MMK and Burchprocedures, thereby assisting in the prevention of incontinence.

Recently, a modified version of the MMK procedure has been developedwhich utilizes bone anchors secured directly to the pubic bone on eitherside of the symphysis for fixation of the UVJ. The apparatus forperforming this modified MMK procedure are sold by Mitek SurgicalProducts, Inc. of Norwood, Mass., and a number of U.S. patents concernthese products (see, e.g., U.S. Pat. Nos. 5,207,679, 5,217,486 and4,899,743). In the Mitek-MMK procedure, a Pfannenstiel incision must bemade in the abdomen in order to provide access to the space of Retzius.The space of Retzius is in actuality a "potential" space in that itcontains various connective tissues and fats which must be dissected inorder to provide sufficient access to this region. In fact, thisconnective tissue, particularly the areolar adventitial tissue,generally breaks down after delivery of a child, and this breaking downof the connective tissue often contributes to the onset of SUI in manywomen.

Once the space of Retzius has been dissected in the Mitek-MMK procedure,small anchors are secured in the pubic bone on either side of the pubicsymphysis. Each of the bone anchors has a suture attached thereto, andthese sutures are threaded through the periurethral tissue on eitherside of the urethra. The sutures are then tied off in the abdomen sothat the periurethral tissue is pulled upward, which in turn restoresthe angle of the urethra at the UVJ, thereby restoring the urethra toits proper location. While the Mitek-MMK procedure is highly effective,it is a lengthy and complicated procedure which can generally only beperformed by highly-skilled surgeons.

The present invention offers a unique anchor-insertion tool for securingan anchor within a patient. This apparatus is particularly suited forlaparoscopic urethropexy, however, its use is not so limited.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed that thesame will be better understood from the following description taken inconjunction with the accompanying drawings in which:

FIG. 1 is a cross-sectional view taken through the midline of a patientwho has lost support of the periurethral tissue at the UVJ, and isthereby suffering from stress urinary incontinence (SUI);

FIG. 2 is the same view as FIG. 1, however the structural defect hasbeen corrected using the methods and apparatus of the present invention;

FIG. 3 is a top plan view of a bone anchor used in the method of thepresent invention;

FIG. 4 is a side plan view of the bone anchor of FIG. 3;

FIG. 5 is a top plan view of a drill tamper tool of the presentinvention wherein a portion of the tool has been broken-away;

FIG. 6 is a side plan view of the tamper tool of FIG. 5;

FIG. 7 is an end plan view of the tamper tool of FIG. 5, taken alongline 7--7 thereof;

FIG. 8 is a top plan view of a bone anchor insertion tool of the presentinvention, wherein a portion of the tool has been broken-away;

FIG. 9 is a side plan view of the insertion tool of FIG. 8;

FIG. 10 is a side plan view of the insertion tool of FIG. 8 with thebone anchor of FIG. 3 loaded thereon;

FIG. 11 is a side plan view of a suture retriever of the presentinvention;

FIG. 12 is an end plan view of the suture retriever of FIG. 11, takenalong the line 12--12 thereof;

FIG. 13 is a top plan view of a suture template of the presentinvention;

FIG. 14 is a side plan view of the template of FIG. 13;

FIG. 15 is a bottom plan view of the template of FIG. 13;

FIG. 16 is an end plan view of the template of FIG. 13, taken along line16--16 thereof;

FIG. 17 is a perspective view of the template of FIG. 13 in use during asurgical procedure with portions of the patient's anatomy cut-away forclarity;

FIG. 18 is a perspective view of an alternative embodiment of the suturetemplate according to the present invention;

FIG. 19 is a perspective view of the insertion tool of FIG. 8 in useduring a surgical procedure with portions of the patient's anatomycut-away for clarity;

FIG. 20 is a perspective view of the surgical procedure of the presentinvention wherein portions of the patient's anatomy cut-away forclarity, and wherein the suture retriever of FIG. 11 is being employed;

FIG. 21 is a perspective view of the surgical procedure of the presentinvention wherein portions of the patient's anatomy cut-away forclarity, and wherein the sutures have been retrieved from thepre-peritoneal region for tying;

FIG. 22 is a perspective view of the space of Retzius, and illustratesthe proper placement of the anchors and sutures employed in the presentinvention;

FIG. 23 is a side plan view of the anchor of the present invention inplace in the pubic bone of a patient, wherein the pubic bone is shown incross-section;

FIG. 24 is a perspective view of the anchor of FIG. 23;

FIG. 25 is a side plan view of the anchor of FIG. 23;

FIG. 25a is another side plan view of the anchor of FIG. 23;

FIG. 26 is a top plan view of the anchor of FIG. 23;

FIG. 27 is an end plan view of the anchor of FIG. 23, viewed from theproximal end towards the distal end;

FIG. 28 is an end plan view of another embodiment of an anchor accordingto the present invention, viewed from the proximal end towards thedistal end;

FIG. 29 is an end plan view of another embodiment of an anchor accordingto the present invention, viewed from the proximal end towards thedistal end;

FIG. 30 is a cross-sectional view of the anchor of the present inventiontaken along the line 30--30 of FIG. 26;

FIG. 31 is a side plan view of an anchor-insertion tool of the presentinvention, wherein a portion of the tool has been cut-away for clarity;

FIG. 32 is a side plan view of the anchor-insertion tool of FIG. 31 withan anchor loaded thereon, said anchor having a suture extendingtherefrom, wherein a portion of the tool has been cut-away orcross-sectioned for clarity;

FIG. 33 is a cross-sectional view of the loaded anchor-insertion tool ofFIG. 32 taken along line 33--33;

FIG. 34 is a cross-sectional view of the loaded anchor-insertion tool ofFIG. 32 taken along line 34--34;

FIG. 35 is a cross-sectional view of the loaded anchor-insertion tool ofFIG. 32 taken along line 35--35;

FIG. 36 is an end plan view of the handle of the anchor-insertion toolof FIG. 31.

FIG. 37 is a top plan view of yet another embodiment of theanchorinsertion tool of the present invention, wherein a portion of theshaft has been broken away;

FIG. 38 is a side plan view of the anchor-insertion tool of FIG. 37;

FIG. 39 is a top plan view of the tip portion of the anchor-insertiontool of FIG. 37;

FIG. 40 is a side plan view of the tip portion of the anchor-insertiontool of FIG. 37;

FIG. 41 is a top plan view of the anchor-insertion tool of FIG. 37, witha pair of suture threaders loaded therein;

FIG. 42 is a top perspective view of an alternative embodiment for thesurgical template of the present invention;

FIG. 43 is a bottom perspective view of an alternative embodiment forthe surgical template of the present invention;

FIG. 44 is a top plan view of another embodiment of the drill tampertool of the present invention, wherein a portion of the shaft has beenbroken away;

FIG. 45 is a side plan view of the drill tamper tool of FIG. 44;

FIG. 46 is a side plan view of another embodiment of the sutureretriever of the present invention;

FIG. 47 a top plan view of the suture retriever of FIG. 46; and

FIG. 48 is a side plan view of the retrieving end of the sutureretriever of FIG. 46.

SUMMARY OF THE PREFERRED EMBODIMENTS

It is an object of the present invention to provide an improvedanchor-insertion tool for use in a laparoscopic urethropexy procedure.

It is another object of the present invention to provide an improvedanchor-insertion tool wherein suture tails extending from the anchor canbe controlled during the insertion process in order to facilitate tyingof the sutures.

It is yet another object of the present invention to provide apre-loaded anchor-insertion tool.

It is still another object of the present invention to provide asurgical template and a suture retriever for use in a laparoscopicurethropexy procedure.

The forgoing object can be accomplished, in accordance with one aspectof the present invention, by providing an anchor-insertion tool forsecuring an anchor having a suture extending therefrom to a structurewithin a patient's body. The anchor-insertion tool comprises an elongateshaft having distal and proximal ends, an anchor-receiving tip at saiddistal end, at least one groove extending from said tip at leastpartially along the length of said shaft, and at least one depressionextending about the circumference of said shaft and intersecting saidgroove. The anchor-insertion tool further preferably comprises at leastone retaining band positioned in said depression, wherein a sutureextending from an anchor positioned on said tip may be slidably heldwithin said groove by said retaining band. A handle may also be providedat the proximal end of said shaft.

The anchor-insertion tool may also have a second groove extending fromthe tip and at least partially along the length of the shaft, whereinthe depression also intersects this second groove. The grooves mayextend along opposite side of said shaft. A second depression preferablyextends about the circumference of the shaft, wherein this seconddepression intersects both of said grooves. A second retaining band maybe positioned within said second depression.

In order to ensure that elastic bands slidably hold the suture in place,the grooves should be deeper than the depressions. The retaining bandsalso preferably comprise elastic O-rings. A suture threader isoptionally provided, and this threader comprises a wire having distaland proximal ends, and a loop at said distal end. The threader ispositioned within the grooves and beneath said retaining bands such thata suture may be inserted into said loop and said threader may then bepulled away from said groove in order to thread the suture into thegroove beneath said retaining band. The threader further has a handle atits proximal end, wherein said loop is positioned adjacent said tip, andwherein said threader may be pulled away from said groove by means ofsaid handle. A pair of such suture threaders may be provided, eachcomprising a wire having distal and proximal ends, and each having aloop at their distal ends, one of said threaders positioned within eachof said grooves and beneath said retaining bands such that a suture tailmay be inserted into each of said loops and said threaders may then bepulled away from said groove in order to thread the suture tails intosaid grooves beneath said retaining bands. Both of the threaders may besecured to a single handle at their proximal ends.

A loaded anchor-insertion tool of the type described above is alsoprovided, wherein an anchor having a suture extending therefrom ispositioned on said anchor-receiving tip, said suture extending from saidtip along the length of said shaft within said groove, and saidretaining band positioned about said shaft such that said suture is heldbetween said band and said groove. The suture is preferably slidablyheld within said groove by said retaining band. The groove should be atleast as deep as the diameter of said suture, in order to ensure thatthe suture is not exposed during the insertion process. The groove ispreferably longer than the portion of said suture which extends alongthe length of said shaft, thereby further ensuring that no portion ofthe suture is exposed.

A surgical method for laparoscopically securing an anchor to the pubicbone of a patient during a laparoscopic urethropexy procedure is alsoprovided. This surgical method comprises the steps of:

(a) providing a loaded anchor-insertion tool comprising, in combination:

an anchor-insertion tool comprising an elongate shaft having distal andproximal ends, an anchor-receiving tip at said distal end, and at leastone groove extending from said tip at least partially along the lengthof said shaft;

an anchor having a suture extending therefrom; and

at least one retaining band;

wherein said anchor is positioned on said anchor-receiving tip, saidsuture extends from said tip along the length of said shaft within saidgroove, and said retaining band is positioned about said shaft such thatsaid suture is held between said band and said groove;

(b) inserting the distal end of said loaded tool through a cannula intothe patient's body; and

(c) securing said anchor to the pubic bone of the patient.

The cannula preferably comprises the operative channel of a laparoscope.This surgical method may also comprise the step of laparoscopicallycreating a bore in the pubic bone, such that the anchor is secured tothe pubic bone by urging the anchor into said bore. The insertion toolmay further comprise a handle at its distal end, and the surgical methodmay thus further comprise the step of pulling said insertion tool awayfrom said bore and said anchor which is secured in said bore by means ofsaid handle, such that said suture slides beneath said band therebyensuring that said suture extends between said anchor and said insertiontool.

A surgical template for guiding at least one suture through theperiurethral fascia and vaginal mucosa adjacent a patient's urethraduring a urethropexy procedure is also provided. This templatecomprises:

(a) first and second wing members extending laterally from oppositesides of the template;

(b) at least one suture guide aperture positioned in each of said wingmembers at a predetermined location; and

(c) a groove extending along the under surface of each of said wingmembers and intersecting said apertures;

wherein said grooves act to guide the insertion of the tip of a sutureretriever into said apertures when said template is positioned withinthe vagina of a patient. The under surface of said wing members adjacentsaid apertures is preferably beveled in order to assist in manipulationof a suture retriever inserted through said apertures, and the uppersurface of said wing members adjacent said apertures is likewisebeveled.

A suture retrieval tool for use in a laparoscopic urethropexy procedureis also provided, this retrieval tool comprising:

(a) a retrieving end comprising a rigid shaft and a sharp tip capable ofpenetrating tissue, said shaft having a longitudinal axis, said tiphaving a width less than the that of said shaft; and

(b) a handle having a longitudinal axis;

whereby said retrieving end may be inserted into a vagina, through thevaginal mucosa and periurethral tissue adjacent a urethra, and into thespace of Retzius, such that said retrieving end may be employed to snarea suture positioned in the space of Retzius for retrieving said sutureinto the vagina The shaft should be round and the tip is substantiallyflat. The tip may further have a sharpened distal end and a suture slotlocated proximally of said distal end, said slot having and entrancethereto, and said slot capable of snaring a suture therein. The entranceto the slot is spaced inwardly from said shaft.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings in detail, wherein like numerals indicateidentical elements throughout the views, FIG. 1 is a cross-sectionalview taken along the midline of a patient suffering from stress urinaryincontinence (SUI). For reference, FIG. 1 depicts bladder 1, urethra 2,urethra-vesicular junction (UVJ) 3, periurethral tissue 4, vagina 5,uterus 6, pubic symphysis 7, and space of Retzius 8. In this patient,urethra 2 and the associated periurethral tissue 4 have sagged intovagina 5. During periods of stress such as coughing or sneezing,pressure will be exerted on bladder 1. Due to the collapse of urethra 2,the surrounding musculature will be unable to provide sufficientcounteractive pressure on urethra 2 to prevent loss of urine duringthese periods of stress. As known from the methods of the prior art,particularly the MMK procedure, fixation of periurethral tissue 4 at UVJ3 on either side of urethra 2 will act to support the urethra andprevent the sagging of urethra 2 into vagina 5. This in turn will enablethe surrounding musculature to provide sufficient pressure on urethra 2to prevent loss of urine during moments of stress.

FIG. 2 depicts the resulting support of urethra 2 at UVJ 3 by means ofthe surgical procedure of the present invention. It should first benoted that pubic bone 12 is shown in FIG. 2, and is that portion of thepubic bone lying immediately to the right of the pubic symphysis. Aswill be more fully understood later, the anchors of the presentinvention are secured in the pubic bone on either side of the pubicsymphysis. A bore 13 has been produced in pubic bone 12, and anchor 9has been secured within bore 13. It should be noted that bore 13 andanchor 9 have been enlarged for purposes of clarity. A suture 10 issecured to anchor 9, and the two tails of suture 10 extend downwardlythrough the space of Retzius 8 into vagina 5. The tails of suture 10extend into the vagina immediately to the right of urethra 2 throughperiurethral tissue 4 at UVJ 3. In the vagina, the two tails of suture10 are tied to one another such that suture 10 provides an upward forceon periurethral tissue 4 on the right side of urethra 2 adjacent UVJ 3.An identical anchor and suture combination is secured to the pubic boneon the left side of the pubic symphysis, and the suture enters thevagina in a similar fashion as before in order to provide an upper forceon periurethral tissue 4 on the left side of urethra 2. In this fashion,the sutures on either side of the urethra act to restore the angle ofthe urethra at the UVJ.

As will be described in further detail below, the securing of theanchors to pubic bone 12 can be accomplished laparoscopically. Suture 10may then be pulled into vagina 5 through periurethral tissue 4immediately adjacent to urethra 2. The two tails of suture 10 may thenbe tied to one another within vagina 5 by hand. It has been found thatthe portion of suture 10 positioned within vagina 5 will beepithelialized within a few days after the procedure. In this fashion,suture 10 will not cause any discomfort or irritation to the patientsince suture 10 will quickly be covered by the epithelium of vagina 5.

SURGICAL TECHNIQUE

A. Preparatory Procedures

Identification of patients suitable for the techniques of the presentinvention may be made by any of the known techniques for identifyingpatients amenable to SUI correction by MMK or similar procedures. Forexample, as discussed previously a cotton swab may be inserted into theurethra until the end of the swab reaches the UVJ. The patient is thenasked to bear down and the movement of the portion of the swab outsideof the urethra is monitored. The external urethral meatus will act as afulcrum for the cotton swab, and a loss of urethral support at the UVJcan be readily identified by the upward movement of the external end ofthe cotton swab. This indicates a downward descent of the urethra at theUVJ, which in turn provides an indication of the structural cause of thepatient's SUI. Other means known in the art, however may be employed toconfirm the diagnosis and/or to rule out other possible causes.

The preoperative preparation of the patient follows standard proceduresfor laparoscopic and gynecological surgeries, however no enema isneeded. The patient is placed in the dorsal lithotomy position, andstandard parenteral antibiotics are applied. Preferably, the patient isalso placed under general anesthesia in order to minimize discomfort.

A Foley catheter (16 French with 10 cc balloon) is then inserted intothe urethra. The balloon of the Foley catheter is inflated, and thecatheter is gently pulled outwardly to ensure proper placement of theballoon at the juncture of the bladder and the urethra. Proper placementof Foley catheter 14 is shown in FIG. 17 wherein a portion of vagina 5has been cut-away for purposes of clarity. Bladder 1 is thereafterdrained in the usual fashion using the catheter so that the bladder willbecome deflated. As will be understood below, maintaining the bladder ina deflated state greatly simplifies the procedure of the presentinvention. In addition, when the template of the present invention isemployed, it is preferable that Foley catheter 14 be positioned in themanner shown in FIG. 17 for reasons which will be described furtherherein.

It is also desirable to measure the length of the patient's urethra inorder to ensure proper placement of the supporting sutures, particularlywhen the template of the present invention is employed. If the suturesare placed too close to the bladder, there is a considerable risk thatthe suture retrieving tool will puncture the bladder. Likewise, if thesutures are placed too far from the UVJ, then proper support of theurethra will not be accomplished. The length of urethra 2 may be readilymeasured by means of any suitable apparatus which may be inserted intothe urethra, as long as the surgeon can be certain that one end of thedevice is positioned at the juncture of the bladder and the urethra(i.e., the UVJ). The simplest means of obtaining this measurement is toprovide graduations along at least a portion of the length of Foleycatheter 14, as shown in FIG. 17. In this fashion, when the balloon ofthe Foley is properly inflated within the bladder and the catheterpulled outwardly to ensure proper seating of the balloon at the junctureof the bladder and the urethra, the length of the urethra can bedetermined using the graduations which will be readily visibleimmediately adjacent the end of urethra 2. While the average urethra is3 cm in length, this can often vary between about 2.7 and about 3.3 cm.As will be more fully understood below, the suture template employed inthe method of the present invention can thus be manufactured indifferent sizes to accommodate the differing urethra lengths. A minimumof two sizes for the template may be provided, and more preferably atleast three different sizes. Alternatively, the graduations may beemployed to facilitate proper placement of a single-sized template.

After the placement of Foley catheter 14 and drainage of bladder 1, aninfra umbilical incision is made in the patient in order to provideaccess to the pre-peritoneal region (the area between the abdominal walland the peritoneum), and more particularly space of Retzius 8. Surgicaldissection of space of Retzius 8 is necessary in order to provide visualaccess to the pubic bone for placement of the bone anchors. Thus,dissection is performed below the fascia, thereby eliminating theadventitial or supportive connective tissue in space of Retzius 8.Although dissection of the connective tissue in space of Retzius 8 canbe accomplished in the typical fashion through a laparoscope, Applicanthas found that a balloon dissection procedure is simpler and moreeffective.

Balloon dissection can be accomplished using the SPACEMAKER surgicalballoon dissector manufactured by General Surgical Innovations ofPortola Valley, Calif., and described in U.S. Pat. No. 5,496,345, whichis herein incorporated by reference. Other equivalent devices can alsobe employed for this purpose. The SPACEMAKER has a guide rod to which asmall balloon is attached. The guide rod is inserted into theinfraumbilical incision until the tip of the rod reaches the pubicsymphysis in the space of Retzius (i.e., between the symphysis and thebladder). The balloon is then inflated in space of Retzius 8 by fillingthe balloon with approximately 300 cc of saline solution or othersuitable fluid, thereby further deflating bladder 1 and separating thesurrounding connective tissue in order to provide sufficient room inspace of Retzius 8 for the fixation procedure of the present invention.The balloon is then aspirated and removed from the pre-peritonealregion.

Although the SPACEMAKER device has an integral trocar sleeve which maynormally be left in the infraumbilical incision for placement of thelaparoscope, the only size currently available is too small for theprocedure of the present invention. Obviously a properly sized integraltrocar sleeve could remain in the patient after removal of the deflatedballoon. Alternatively, and as presently preferred, the SPACEMAKERdevice is removed in its entirety, and a larger 12 mm trocar is insertedinto the infraumbilical incision. A 12 mm WOLF operating/laserlaparoscope (preferably with a WOLF 50/50 beamsplitter camera) isinserted into the trocar sleeve. The pre-peritoneal region is theninsufflated, preferably with CO₂ at a pressure between about 10 andabout 30 mm Hg, thereby further expanding the space of Retzius andproviding excellent laparoscopic vision in this region.

Although the balloon dissection procedure is highly effective, furtherdissection of the space of Retzius is typically necessary in order toprovide the necessary access to the pubic bone and the periurethraltissue. Although this may be accomplished by means of a CO₂ laser or aelectrocautery device through the laparoscope already inserted, it ispresently preferred that an additional 5 mm trocar be inserted in themidline suprapubically. An irrigation/suction/bovie device (such as thatmanufactured by US Surgical) is then inserted into the space of Retziusthrough the smaller trocar sleeve. It should be noted that the trocarsleeve, like the operative channel of the laparoscope, is cannulathrough which surgical instruments may be inserted. Theirrigation/suction/bovie device will not only assist in furtherdissection of the space of Retzius, but will also provide the necessaryirrigation and suction while the other instruments necessary forperforming the present procedure are employed through the infraumbilicaltrocar sleeve. The result of further dissection is that vision farsuperior to the standard MMK or Burch procedures employing a fullabdominal incision will be provided, since it is difficult in theseprocedures for the surgeon to see the underside of the pubic bone wherethe anchors must be placed without the surgeon placing his or her headon the stomach of the patient. In this fashion, unobstructedlaparoscopic access to the pubic bone and the periurethral tissuenecessary for performing the procedure of the present invention isprovided.

B. Creation of Bore in Pubic Bone

It should initially be noted that the procedure of the present inventionmay be employed with any of a variety of bone anchors, provided that theanchor can be readily secured to the pubic bone and a suture can beattached thereto. It is presently preferred, however, that the MITEKbone anchors disclosed in U.S. Pat. No. 5,207,679 (herein incorporatedby reference) be employed for this purpose. As discussed more fullyherein, these anchors are secured in place by pressing them intoproperly-sized bores created in the pubic bone. Additional types ofanchors include those disclosed in U.S. Pat. Nos. 5,522,845, 5,520,696,5,192,303 and 5,527,342 (all of which are herein incorporated byreference). The Acufex Microsurgical, Inc., subsidiary of the AmericanCyanamid Co., of Stamford, Conn. also manufactures yet another type ofanchor which may be employed in the surgical procedure of the presentinvention. Known as TAG anchors, the Acufex anchors are disclosed inU.S. Pat. Nos. 5,258,016, 5,100,417 and 5,224,946, which are alsoincorporated herein by reference. Yet another suitable bone anchor isthat sold by Li Medical of Boston, Mass.

All of the above anchors are secured to bone by insertion into a borepreviously created in the bone. Thus, the MITEK-MMK and relatedprocedures require the use of either a mechanical drill or hand-operatedawl in order to provide the bore for insertion of a bone anchor (such asthose manufactured by Mitek Surgical Products, Inc.) into the pubicbone. While these devices may be readily employed with large abdominalincisions, they cannot be used through a laparoscope for a number ofreasons. Most importantly, these tools must be sufficiently sharp toenable the surgeon to penetrate the hard outer layers of the pubic bone(periosteum and cortical bone). Since the field of vision through alaparoscope may be limited at times, however, it is very risky to employsuch sharp implements as there is a tremendous risk of puncturing thebladder or other soft tissue in the operative area. In addition, as bestshown in FIG. 12, pubic bone 12 falls away from the laparoscope at anangle of approximately 45°. The angularity of pubic bone 12 thereforeprovides vision and operative difficulties which are overcome by theapparatus and methods of the present invention. Simply drilling intopubic bone 12 using prior art apparatus through the laparoscope is notadvisable because the drill or awl tip will tend to slide downwardlyduring the drilling operation because of the manner in which pubic bone12 angles downwardly away from the laparoscope. While the drill tip mayeventually penetrate the hard outer periosteum of the bone, the drillmay enter at an improper location or angle due to downward slippage ofthe drill tip. Ideally one would like to produce a bore in pubic bone 12which is at an angle of approximately 45-degrees to the surface of thebone into which the bore is produced. This angle may, however, bebetween about 20 and about 60-degrees, to thereby provide sufficientsupport for the bone anchor to be placed in the bore thus produced.

Applicant has developed a novel method and apparatus for creating therequired bores in the pubic bone through a laparoscope. The method andapparatus avoid the use of any sharp tips, while still enabling thesurgeon to properly place the bores in the pubic bone without a risk ofmisalignment during the bore creation process. In order to produce thebore without a need for a sharp instrument, a laser is first employed toproduce a cone-shaped crater in the pubic bone at the desired borelocation. The crater is produced in the periosteum and cortical bone,thereby providing access to the soft cancellous, or tribecular, bone. Inthis fashion, a drill tamper tool (to be described further herein) maythen be employed to create the properly-sized bore.

In order to create the starter "crater" in the pubic bone, a CO₂ laser(such as a SHARPLAN 20 watt) is inserted through the laparoscopicchannel, and is employed to create a cone-shaped crater slightly largerthan the diameter of the laser beam in the pubic bone on either side ofthe pubic symphysis. The diameter of the laser beam is preferably about2 mm, and therefore the cone-shaped crater created in the pubic bone isslightly larger than 2 mm in diameter. The crater should be sufficientlydeep to reach the cancellous bone. A crater is established on eitherside of the pubic symphysis directly above and approximately 1 cmlateral to the periurethral fascia at the UVJ. FIG. 21 depicts the spaceof Retzius after creation of bores 9 and 17 in pubic bone 12 on eitherside of pubic symphysis 7. The desired placement location can be readilydetermined through means of the optics of the laparoscope, as properdissection of space of Retzius 8 will provide sufficient vision forproper identification of the appropriate structures in the patient. Ifneeded, the surgeon may use one or more fingers to press upwardly on theperiurethral tissue on either side of the urethra within the vagina inorder to properly position the two starter craters in the pubic bone.

Once access to the cancellous bone has been provided by the cone-shapedcraters created on either side of the pubic symphysis using the laser,the bore for insertion of the anchor may be readily created using thedrill tamper tool of the present invention. Since the cancellous bone issignificantly softer than the periosteum or cortical bone, it is notnecessary that a sharp awl or drill bit be used to create the bore.Rather, a bluntly pointed drill tamper tool may be used, wherein the endof the tamper tool is not sufficiently sharp to puncture the bladder orother soft tissue under normal use. This provides a significantadvantage in that damage to the bladder or other soft tissue structuresin the patient may be readily avoided, and drill guides and the likewhich must be used with the MITEK instruments and similar apparatus canbe avoided. As will be understood, the MITEK drill guides cannotpossibly be employed laparoscopically. The laser employed to create thecone-shaped craters can be readily aligned in the proper location,without risk of slippage or other inadvertent movement during theprocedure. The laser-created craters can then be readily employed toinsure that the bores for anchor placement are created in the exact,desired location.

One embodiment of the drill tamper tool of the present invention isshown in FIGS. 5-7, and comprises an elongate rigid member 20 having adistal end which comprises a conical boring tip 21. End 22 of conicalboring tip 21 preferably has a cross section similar in size and shapeto the crater created in the pubic bone by the laser. In this fashion,alignment of conical boring tip 21 within the crater will be relativelyeasy. It is also preferred that end 22 of conical boring tip 21 be bluntso that it will not penetrate soft tissue such as the bladder duringnormal use (i.e., not sufficiently sharp to penetrate soft tissue ororgans during normal use). Certainly, however, conical boring tip 21should be sufficiently thin and blade-like to permit boring tip 21 tocreate the bore in the soft cancellous bone by use of hand force throughthe laparoscope. In this regard, conical boring tip 21 is preferablyshaped similar to a flat bladed screwdriver. Thus, boring tip 21 hastapered side surfaces 23 and 24 which terminate in portion 25 which isof a circular cross-section. The diameter of circular/cross-sectionportion 25 is identical to the diameter of the bore which will becreated in the pubic bone. By rotating the drill tamper tool whilesimultaneously pressing boring tip 21 into the crater in the pubic bone,the desired bore will be readily created therein. The diameter ofportion 25 is also approximately the same as the body of the anchor tobe inserted into the bore.

In order to ensure sufficient support for the bone anchors of thepresent invention, it is also important that the anchor be seated deepwithin the pubic bone. In order to ensure proper depth of the bore,therefore, collar 26 is provided on the drill tamper tool. Collar 26 isof a larger diameter than conical boring tip 21, and therefore will actas a stop preventing further penetration of the drill tamper tool intothe bone. Although collar 26 is shown as tapering in diameter betweenconical boring tip 21 and intermediate portion 27, it is also possiblethat collar 26 simply comprise a non-tapered end of intermediate portion27. Intermediate portion 27 has a diameter significantly greater thanthat of conical boring tip 21, and is positioned on the opposite end ofcollar 26. Intermediate portion 27 not only allows the provision ofcollar 26, but also adds rigidity to the tamper tool. Intermediateportion 27, however, should be significantly smaller in diameter thanthe operative channel of the laparoscope so that sufficient vision ofthe operative region is provided. Preferably, the length of conicalboring tip 21 is between about 1, and 3 cm, and most preferably about1.4 cm. Intermediate portion 27 is preferably between about 2, and 6 cm,and most preferably about 5 cm.

In order to provide stability during the boring procedure, cylindricalguide portion 28 is also included on the drill tamper tool. Guideportion 28 has first end 29 and second end 30. First end 29 is attachedto intermediate portion 27 at the opposite end of collar 26. Cylindricalguide portion 28 preferably has a diameter slightly less than theoperative channel of the laparoscope. In this fashion, guide portion 28provides the necessary stability within the laparoscope to ensure properplacement of the bores. Second end 30 of guide portion 28 is preferablyattached to handle 31. While handle 31 is shown as having a flat endportion 32 and curved hand grip surfaces 33, handle 31 can be of avariety of forms and still be sufficient for purposes of the presentinvention. Handle 31 facilitates the proper manipulation of conicalboring tip 21 through the laparoscope, and provides a sufficiently firmsurface 32 upon which force may be applied to complete the boringoperation. Guide portion 28 preferably has a length between about 50 andabout 55 cm, and most preferably about 52 cm. The overall length of thedrill tamper tool therefore permits sufficient access to the pubic bone,while also providing an ergonomically-effective boring operation throughthe laparoscope and ensuring that the tool does not interfere with theanesthesiologist.

FIGS. 44-45 depict an alternative embodiment for the drill tamper toolof the present invention wherein the intermediate portion has beeneliminated.

Thus, the drill tamper tool of FIG. 44 comprises an elongate, rigidshaft 328, which corresponds to the guide portion in the embodiment ofFIGS. 5-7. At one end of shaft 328 is handle 331 which serves the samepurpose as described previously. At the opposite end of shaft 328 isboring tip 321. Boring tip 321 is as described previously, and thus hasblunt end 322, circular cross-section portion 325, and tapered sidesurface 323 (the opposite tapered side surface is not visible). Collar326 is positioned between boring tip 321 and shaft 328, and once againacts as a stop to limit penetration to the desired depth. Collar 326 ispreferably tapered as shown in order to provide sufficient laparoscopicvision. Boring tip 321 has a length of between about 1 and about 3 cm,preferably about 1.4 cm. Shaft 328 has a length of between about 45 andabout 60 cm, preferably between about 50 and about 52 cm, therebyproviding laparoscopic access to the pubic bone. Shaft 328 alsopreferably has a diameter which is only slightly less than the operativechannel of the laparoscope in order to provide stability and preventinsufflation gas from escaping. While end 322 of tip 321 may be blunt aspreviously described, in the embodiment of FIGS. 44-45 it has a pointedtip.

C. Insertion Of Bone Anchors In Pubic Bone

One preferred anchor for use in the present invention is shown in FIGS.3 and 4, and is identical to that disclosed in U.S. Pat. No. 5,207,679.Anchor 9, which is preferably made of titanium alloy or other suitablematerial, has a cylindrical body 40 and a conical end 44 attachedthereto. At least two flexible barbs 41 curve outwardly away from body40. A groove 42 is provided on either side of body 40 at the endopposite to conical end 44. In addition, cylindrical end 45 extends awayfrom body 40 adjacent groove 42. The longitudinal axis of cylindricalend 45 is aligned with the longitudinal axis of body 40. The diameter ofcylindrical end 45 is preferably equivalent to the diameter of body 40within grooves 42 positioned on opposite sides of body 40. As will beunderstood below, this structure facilitates the attachment of anchor 9to an insertion tool.

As best shown in FIG. 4, body 40 and cylindrical end 45 have an aperture43 provided therethrough. Aperture 43 is sized so as to accommodate asuture appropriate for the fixation procedure of the present invention.It is preferred that a size 0 GORE-TEX suture be employed, and thusanchor 9 and its accompanying aperture 43 should be sized accordingly.The use of a GORE-TEX suture is preferred for reasons of strength andnon-elasticity. Certainly other types of sutures could be employed ifnecessary. A portion of suture 10 is shown in FIG. 3 having beeninserted through aperture 43.

The insertion of anchor 9 is relatively straightforward, and merelyrequires that the anchor be pressed completely into the bore which haspreviously been created in the pubic bone. Preferably, anchor 9 isinserted into the bore in the pubic bone until conical end 44 reachesthe distal end of the bore. The bore should be at least as long as thelength of anchor 9, however, it is preferably considerably longer toensure sufficient support for the anchor. As anchor 9 is pressed intothe bore, flexible barbs 41 will be compressed against body 40 as theyare inserted past the hard periosteum and cortical bone surrounding thebore. Once within the bore, however, flexible barbs 41 will tend tospring back into the soft cancellous bone, thereby securing the anchorin place. A slight tug on the tails of the suture 10 will also causebarbs 41 to further deploy.

In order to insert anchor 9 into the bore previously created in thepubic bone, the anchor insertion tool shown in FIGS. 8-10 may beemployed. Thus, after the drill tamper tool has been employed to createthe necessary bores, the anchor insertion tool of the present inventionhaving an anchor and threaded suture loaded there, is inserted into thelaparoscope for proper seating of anchor 9.

The anchor insertion tool of the present invention comprises a rigidelongate member 50 having a handle 51 at one end, and ananchor-receiving tip 52 at the opposite end of elongate member 50. Aswas the case with the drill tamper tool, handle 51 can be of anyvariety, and that shown is only one embodiment for this handle.Anchor-receiving tip 52 is similar in construction to that shown inFIGS. 4-6 of U.S. Pat. No. 5,207,679. Anchor-receiving tip 52 isconstructed so as to matingly receive anchor 9 in order to facilitateinsertion of anchor 9 into the bore. As will be apparent, thelongitudinal axis of anchor-receiving tip 52 should be aligned with thelongitudinal axis of elongate member 50. Anchor-receiving tip 52 iscylindrical in nature, having a diameter approximately equivalent tobody 40 of anchor 9. In this manner, at least a portion ofanchor-receiving tip 52 may pass through the bore in the pubic boneduring the anchor insertion process to properly seat the anchorcompletely within the bore.

Anchor-receiving tip 52 has a pair of guide tabs 53 extending from theend of anchor-receiving tip 52 on either side thereof. Guide tabs 53 aresized and shaped so as to be matingly received within grooves 42positioned on either side of anchor 9. Anchor-receiving tip 52 also hasa cylindrical slot 54 aligned with the longitudinal axis of tip 52.Cylindrical slot 54 should correspond in size and shape to cylindricalend 45 of anchor 9 in order to matingly receive the same. It is alsopreferable that the distance between guide tabs 53 be slightly smallerthan the distance between the corresponding grooves 42 on anchor 9. Inthis fashion, guide tabs 53 as well as cylindrical slot 54 will applycompressive force against anchor 9 thereby more securely holding anchor9 in place when loaded within anchor-receiving tip 52.

Since suture 10 will extend outwardly on either side of anchor 9, it ispreferable to provide a means for ensuring that suture 10 is not abradedby the bone surrounding the bore during the insertion process. Thus, apair of tapered grooves 55 are provided on either side of the anchorinsertion tool, and extend from the end of anchor-receiving tip 52 alongat least a portion of the length of elongate member 50. As best shown inFIG. 10 wherein anchor 9 has been loaded upon the insertion tool,grooves 55 ensure that the sutures will be protected by anchor-receivingtip 52 and a portion of elongate member 50 during the insertion process.Since any nicks in the suture may compromise the strength and permanencyof the fixation, it is important to ensure that the suture is notdamaged in any fashion.

Anchor-receiving tip 52 should also be of the proper length to ensuredeep placement of anchor 9 completely within the bore. Thus, the lengthof the combination of anchor-receiving tip 52 and bone anchor 9 whenloaded in the manner shown in FIG. 10 should be equivalent to the sizeof the bore created in the pubic bone. Since the diameter of elongatemember 50 is significantly greater than that of anchor-receiving tip 52,distal end 56 of elongate member 50 will firmly abut the pubic bone oncethe anchor has been completely inserted into the bore. In this manner,the surgeon can be certain that the anchor has been seated to itscomplete and proper depth.

As was the case with the drill tamper tool of the present invention,elongate member 50 further comprises an intermediate section 57 and aguide portion 58. Intermediate portion 57 should have a diametersufficiently less than that of the laparoscope in order to provideadequate vision for the surgeon, and intermediate portion 57 also hasdistal end 56 described above. Preferably, intermediate portion 57 has alength between about 2 and about 6 cm, most preferably about 5 cm. Itshould be kept in mind that, as shown in FIG. 10, suture 10 will extendalong the length of intermediate portion 57 on either side thereof. Thisconsideration must be kept in mind when sizing the diameter ofintermediate portion 57 to ensure not only that it can be easilyinserted through the laparoscope, but also to ensure adequate vision.

Guide portion 58 will necessarily be slightly smaller than the diameterof the guide portion for the drill tamper tool previously described,since, as shown in FIG. 10, suture 10 will extend along either side ofguide portion 58. With this in mind, the total of the diameter of guideportion 58 and twice the diameter of suture 10 should be only slightlyless than the inside diameter of the operative channel of thelaparoscope. In this fashion, guide portion 28 provides a rigid supportfor the surgeon during the anchor insertion process. Preferably, guideportion 58 has a length between about 50 and 55 cm., most preferablyabout 52 cm. This provides an overall inserter length comparable to thatof the drill tamper tool, thereby providing the same advantages withregard to the tamper tool length.

In order to effectively employ the procedure of the present inventionlaparoscopically, it is necessary that the two tails of suture 10 becontrolled as much as possible. If the sutures are permitted to hangaway from anchor 9 or the anchor insertion tool, the tails willgenerally become balled within the space of Retzius, thereby making thesuture tying procedure difficult, if not impossible. Although thesutures may be held against the anchor insertion tool by hand, Applicanthas developed a more effective manner of accomplishing this. Thus, firstand second shouldered depressions 59 and 60 are preferably providedabout the circumference of guide portion 58. A small rubber band 61 (asshown in FIG. 10), or other suitable elastic band, may be held withineach of the two shouldered depressions, with the two tails of suture 10held beneath rubber band 61 on either side of guide portion 58 as shown.First shouldered depression 59 is preferably positioned approximately 10cm from the ends of guide tabs 53. Second shouldered depression 60 ispreferably positioned about 40 cm from guide tabs 53. Both shouldereddepressions act, in conjunction with an elastic band contained therein,to hold suture 10 in place on the sides of the anchor insertion tool.

In addition to holding the suture in place on the anchor insertion tool,the shouldered depression/elastic band combination further improves thelaparoscopic procedure of the invention by not only assisting in seatingthe anchor, but also in the suture retrieval process. As shown in FIG.20, the anchor insertion tool of the present invention, with apre-loaded anchor and suture assembly attached thereto, is insertedthrough the laparoscope for placement of the anchor as previouslydescribed. Once the anchor has been seated within the bore, the anchorinsertion tool is then pulled outwardly utilizing handle 51 containedthereon. The combination of shouldered depressions 59 and 60 and rubberband 61 act to provide tension in suture 10 which in turn pullsoutwardly on anchor 9 which is now contained in the bore. This outwardforce on anchor 9 will cause flexible barbs 41 to extend outwardly intothe cancellous bone surrounding the bore, thereby further securinganchor 9 in position. In other words, this outward force on suture 10 bythe drag created by the shoulder depression/elastic band combinationwill act to deploy the previously compressed barbs 41 on anchor 9,thereby rigidly securing anchor 9 within the bore.

In order to facilitate the surgical procedure of the present invention,the drill tamper tool and the anchor-insertion tool described above maybe provided in the form of a reusable surgical kit.

D. Fixation of Periurethral Tissue At the UVJ Via Suturing

Once the anchor and suture assembly have been secured within the borecreated in the pubic bone, it is next necessary to utilize the two tailsof the suture to elevate the periurethral tissue on the correspondingside of the urethra at the UVJ. Applicant has found that the mosteffective means for accomplishing this is to pull each tail of thesuture through the periurethral tissue into the vagina. In this fashion,the two tails may then be easily tied to one another within the vaginato provide the necessary support, and eliminating any need forlaparoscopic suture tying. Obviously, however, a means for retrievingthe suture tails must be provided.

The method of suture retrieval is best shown in FIG. 20, which is aperspective view of the procedure with portions of the patient's anatomycut-away for purposes of clarity. As shown in FIG. 20, as the anchorinsertion tool of the present invention is partially withdrawn from thepatient through the laparoscope, first shouldered depression 59 incombination with rubber band 61 will cause both suture tails to betensioned between the anchor and the anchor insertion tool as shown.Were this not the case, the suture tails would merely fall into thespace of Retzius similar to a ball of yarn, and thereby be difficult (ifnot impossible) to retrieve. While the suture tails could be tensionedbetween the anchor and the anchor insertion tool by pulling outwardly onthe sutures, this would unnecessarily require an additional pair ofhands. Thus, the shouldered depression/rubber band combination is alsoeffective in this regard.

Once the anchor insertion tool has been partially removed in order totension the suture tails in the manner shown in FIG. 20, a sutureretrieving tool may be inserted into the vagina and then pressedupwardly on one side of the urethra into the space of Retzius in orderto retrieve one of the suture tails in the manner shown. Thus, thesuture retrieving tool must have a sharp point capable of passingcompletely through the full thickness of the periurethral fascia andvaginal mucosa adjacent the urethra. The suture retrieval tool must alsohave a means for grasping the suture tail and pulling the tail backthrough the full thickness of the periurethral and vaginal mucosa bymeans of the same entry hole created by the sharp point. Each tail ispulled into the vagina in this fashion at the proper location.Preferably, one tail is pulled into the vagina approximately 1 cm fromthe urethra at the UVJ, and the other tail is pulled into the vaginaapproximately 2 cm lateral from the urethra. In other words, each tailpenetrates the periurethral tissue along an imaginary line extendingsubstantially perpendicularly away from the urethra. Each tail may thenbe pulled out of the vagina for purposes of tying.

The suture tails are tied to one another using a series of standardsurgeon's knots, and each knot is slid by hand to the point in thevagina at which the suture tails were previously retrieved. The tailsare tied to one another in a sufficiently tight fashion so that suture10 creates an upward force on the periurethral tissue adjacent theurethra in order to elevate the urethra at the UVJ and restore theurethra to its proper angle. The position of the urethra can be readilyobserved by the surgeon as this procedure is performed, thereby ensuringthat the urethra is restored to the desired angle. The entire procedure(anchor insertion, suture retrieval, etc.) is then repeated for theanchor placed on the opposite side of the pubic symphysis, and thesuture tails of that anchor are pulled into the vagina through theperiurethral tissue on the opposite side of the urethra as the firstsuture tails. Tying is then performed in the same fashion, therebyelevating the other side of the urethra to thereby completely restorethe urethral angle at the UVJ.

The result of this process is best shown in FIG. 2, wherein it is shownthat suture 10, and the corresponding suture on the opposite side of theurethra have restored the urethra to its proper angle. It should benoted that at no time do the sutures pull upward directly beneath theurethra, since doing so would create the risk that the suture wouldcause urethral blockage. After tying, the remaining tails of suture 10are cut at the knot. After the suture tails have been cut adjacent tothe knot, it is preferred that the knot be moved into the abdominalcavity. This can be accomplished merely by pulling lightly on oneportion of the suture within the vagina, which thereby causes the sutureto be pulled through one of the holes previously traded in the vaginalmucosa and periurethral fascia towards anchor 9. In other words, thesuture acts much like a rope on a pulley system, such that when oneportion of the tied suture is pulled downwardly into the vagina, theopposite side will traverse upwardly, carrying the knot with it into theabdominal cavity. In this manner, the knot will not be present withinthe vagina where it might cause irritation. The portion of suture 10remaining in the vagina will epithelize within three to four days, andthe patient will no longer sense that the sutures are in place. Theresult is a permanent fixation of the periurethral tissue on both sidesof the urethra, thereby restoring the urethra to its correct angle andeliminating the SUI. After completion of the tying process, the surgicalarea within the patient is flushed with a dilute lidocaine solution, thelaparoscope and trocars removed, a stronger lidocaine solution isapplied to the incision sites, and the incisions are closed in the usualfashion. The Foley catheter may then be removed, and the patientpermitted to recover in the usual fashion. Normal everyday activitiesmay be resumed within 2-3 days.

E. Suture Retriever

In order to pull the tails of suture 10 through the entire thickness ofthe periurethral fascia and vaginal mucosa, various tools can beemployed. For example, a U.S. Surgical Auto-Stitch tool may beeffectively employed for this purpose. It is critical, however, that thetool employed being capable of readily be inserted through theperiurethral tissue from the vagina into the space of Retzius, whilealso being capable of grasping the suture tails. It is also criticalthat the surfaces contacting suture 10 be perfectly smooth in order toeliminate the risk of nicks or cuts in suture 10 which would obviouslycompromise the effectiveness of the procedure. Applicant has developed anovel suture retriever for accomplishing this purpose which provides aconvenient and simple means of retrieving the suture tails.

The suture retrieval tool of the present invention is depicted in FIG.11, and comprises metal retrieving end 65, midshaft 66, and handle 67.Midshaft 66 and handle 67 may be singularly molded from polycarbonate ora similar FDA-approved material in the typical fashion. As shown in FIG.12, handle 67 is also preferably knurled in order to facilitate graspingand manipulation of the retriever. Metal retrieving end 65 is preferablymade of stainless steel and can be securely molded into distal end 68 ofmidshaft 66.

Metal retrieving end 65 comprises a rigid, rod-like shaft 69, and asharp tip 70 capable of penetrating the periurethral tissue. Thediameter of distal end 68 is preferably significantly greater than thatof shaft 69, and will act as a stop in order to limit the penetration ofthe suture retrieval tool into the space of Retzius. Thus, the length ofshaft 69 and tip 70 may be selected so as to ensure that when the sutureretrieval tool is inserted into the space of Retzius through the vaginathat sharp tip 70 will generally be incapable of striking anysurrounding soft tissue.

Retrieving end 65 further comprises a return leg 71 which extends awayfrom sharp tip 70 in the same direction of shaft 69. Shaft 69, returnleg 71 and the underside of sharp tip 70 thus create an invertedU-shaped region capable of ensnaring suture 10 for retrieval purposes.The distance between return leg 71 and shaft 69 in the region of theinverted U-shape is preferably approximately the same diameter as suture10. In this fashion, and as shown in FIG. 20, after sharp tip 70 haspenetrated the periurethral tissue adjacent the vagina in order to enterthe space of Retzius, the inverted U-shape may be pulled downwardly overa suture tail, thereby snaring the suture. Metal retrieving end 65 maythen be pulled back through the periurethral tissue, and the tail ofsuture 10 will remain snared between return leg 71 and shaft 69 directlybeneath sharp tip 70.

Although the suture tail will slide within the U-shaped region, it willnevertheless be pulled into the vagina.

One critical feature of the suture retriever of FIG. 12 is that theinner surfaces of metal retrieving end 65 which contact suture 10 mustbe rounded and smooth in order to permit suture 10 to freely slidewithin the inverted U-shaped portion as the retriever is withdrawn. Thisprevents nicking or fraying of the suture while still permitting thesuture tail to be withdrawn. Thus, the only sharp portion of metalretrieving end 65 is sharp tip 70.

While it is possible that handle 67, midshaft 66, and metal retrievingend 65 may all be positioned along the same longitudinal axis therebyforming a rigid, elongate structure, Applicant has found that theprocess of the present invention can be simplified if the elements ofthe retriever have the angular relationship indicated in FIG. 11. Thisis particularly true when the template of the present invention (to bedescribed further herein) is employed. Thus, metal retrieving end 65preferably is positioned at an angle of between about 100 degrees andabout 130 degrees, most preferably about 120 degrees, to midshaft 66(this angle is indicated as A in FIG. 11). Likewise, handle 67 ispreferably positioned at an angle of between about 100 degrees and about130 degrees, most preferably about 120 degrees, to midshaft 66 (thisangle is indicated as B in FIG. 11). Thus, the longitudinal axis ofshaft 69 of metal retrieving end 65 will be parallel to the longitudinalaxis of handle 67. In this fashion, when the retriever of the presentinvention is employed midshaft 66 will generally be positioned parallelto the longitudinal axis of the vagina. Metal retrieving end 65 willthen extend upwardly through the periurethral tissue into the space ofRetzius as desired. As best shown in FIG. 20, handle 67 will therebyextend downwardly outside of the vagina, and thus sharp tip 70 may bereadily forced through the periurethral tissue as desired merely bypushing upwardly on handle 67.

As shown in FIG. 11, the transitions between handle 67 and midshaft 66as well as between midshaft 66, and retrieving end 65 should be gentlycurved in order to ease placement. It should be noted that angles A andB can vary significantly, however it is preferred that they be as closeto one another as possible so that the parallel relationship of handle67 and retrieving end 65 is maintained. In addition, the presentconfiguration ensures that the retrieving end 65 will enter the space ofRetzius at an angle of approximately 90 degrees to the tensioned suturetails (i.e., the suture tails tensioned between the anchor and theanchor insertion tool). This parallel relationship allows for effectivesnaring of the suture, as well as improved vision of the retrievalthrough the laparoscope.

Preferably, midshaft 66 is between about 2 and about 6 cm. in length,most preferably about 4 cm. The cross-sectional area of midshaft 66should merely be a size chosen to provide the necessary rigidity whilealso not blocking vision within the vagina during the procedure.Likewise, handle 67 is preferably about 4 cm long, however the length isnot as critical since handle 67 remains completely outside of the body.The diameter of handle 67 should be chosen so as to provide acomfortable and secure means of grasping the suture retrieval tool.Preferably, handle 67 is about 3 cm in diameter.

An alternative, and presently preferred embodiment for the sutureretrieval tool of the present invention is shown in FIGS. 46-48. In thisembodiment, the suture retrieval tool once again comprises metalretrieving end 265, a midshaft 266 and a handle 267. The longitudinalaxis of these three elements are as shown by the dashed lines. Midshaft266 and handle 267 may be singularly molded from polycarbonate or asimilar FDA-approved material in the typical fashion. Handle 267preferably is curved in the manner shown so as to provide a comfortablegrip for the surgeon.

Metal retrieving end 265 comprises a rigid, rod-like shaft 269 and a tipof portion 270. As best shown in FIG. 47, tip portion 270 is preferablyflat in nature, and, as shown in FIG. 48, has a width L which is lessthan the width or diameter of shaft 269. Tip 270 has a sharpened distalend 274, and a suture slot 271 located approximately of the distal end.Slot 271 also has an entrance 275 thereto, and entrance 275 is spacedinwardly from shaft 269. In other words, the center line of tip portion270 is slightly off-set from the longitudinal axis of shaft 269. In thismanner, a suture may be snared in the manner described previously byallowing the suture to enter entrance 275 until it rests within slot271. When the tip of the suture retrieval tool is then retracted backinto the vagina, the off-set between opening 275 and shaft 269 willensure that leg 276 adjacent suture slot 275 will not snag against thepatient's tissue. In other words, since shaft 269 tends to create apuncture hole in the patient's tissue which is greater than the width oftip 270, the tip will not snag on the edges of this puncture hole.

In addition, shaft 269 preferably has a diameter which is significantlygreater than that of the suture employed. In this manner, shaft 269 willcreate a puncture hole is the soft tissue which is larger than the knotin the suture. In this manner, the knot may be moved from the vaginainto the abdominal cavity of the patient through this puncture hole inthe manner previously described. In order to facilitate insertion ofshaft 269 into the patient, tapered walls 277 are provided. Taperedwalls 277 provide a smooth transition between flat tip 270 and roundedshaft 269.

In the embodiment of FIGS. 46-48, the angular arrangement of retrievingend 265, midshaft 266 and handle 267 is preferably modified somewhatfrom that previously described in that the angle between midshaft 266and retrieving end 265 is greater than that previously described.Applicants have found that by opening this angle further, the surgeonwill be better able to avoid striking blodd vessels on the undercarriageof the pubic bone with the sharp distal end 274. Thus, while angle Mbetween midshaft 266 and handle 267 is preferably between about 120degrees and about 135 degrees, the angle between retrieving end 265 andmidshaft 266, however, is between about 135 degrees and about 155degrees, more preferably about 150 degrees. In order to add strength andrigidity, a small extension to 278 on midshaft 266 has a longitudinalaxis corresponding to that of retrieving end 265. Extension 278 may behollow, thereby allowing retrieving end 265 to be inserted and securedtherein. The diameter of extension 278, as well as the remainder ofmidshaft 266, is preferably larger than that of shaft 269. This allowsend 268 of extension 278 to act as a stop which prevents the midshaftfrom penetrating the soft tissue once the retrieving end is insertedthrough the soft tissue of a patient.

F. Surgical Template

While the placement of the sutures at the UVJ may be accomplished bymerely feeling for the correct location within the vagina by hand,particularly in relation to the ball of the Foley catheter, Applicanthas developed a novel template which greatly simplifies proper placementof the sutures. This device not only prevents bladder injury, urethralinjury, or vascular accidents, the template also ensures a properdistance between the two suture tails to ensure that there is adequateperiurethral tissue between the tails to provide the necessary support.Obviously if the suture tails are placed too close to one another, thereis a risk that the suture will tear through the periurethral tissue andeliminate the fixation. Thus, a template is provided wherein thetemplate has at least two apertures which may be properly positioned oneither side of the urethra. The suture retriever may then be insertedthrough these apertures and thereafter through the periurethral tissuein order to snare the suture tails in the manner described previously.

One embodiment for the surgical template is depicted in FIGS. 13-17. Thetemplate comprises a trough 80 of arcuate cross-section, wherein trough80 is sized so as to cradle the patient's urethra when properlypositioned. First and second wing members 81 and 82 extend away fromopposite sides of trough 80, preferably perpendicularly to thelongitudinally axis of trough 80 in the manner shown. Most preferablywing members 81 and 82 extend perpendicularly away from opposite sidesof trough 80 at the upper most edges 83 and 84 of trough 80. First andsecond suture guide apertures 85 and 86 are positioned in each of thewing members 81 and 82 as shown. The guide apertures are positioned sothat when the urethra of the patient is properly positioned withintrough 80, guide apertures 85 and 86 on each wing will indicate theproper location for the sutures. First suture guide aperture 85 ispositioned so that the first tail of suture 10 will penetrate theperiurethral tissue approximately 1 cm from the urethra adjacent theUVJ. Second guide aperture 86 is preferably positioned about 1 cmfurther away from the urethra along a line perpendicular to thelongitudinal axis of trough 80. In other words, the distance betweenfirst suture guide aperture 85 and second suture guide aperture 86 ispreferably about 1 cm. In this manner, the surgeon can be confident thatsufficient periurethral tissue will be present between the two suturetails.

It is certainly possible that the template of the present invention maymerely be held in place by hand, and in fact the downwardly slopingnature of the underside wing members 81 and 82 are suitable forplacement of the surgeon's fingers thereunder. Additional alignmentmeans are preferably provided, however at a minimum, end wall 87 isprovided at the end of trough 80 furthest away from the suture guideapertures. Thus, as long as the template is properly sized for thelength of the patient's urethra, the surgeon may hold the template inplace with end wall 87 abutting the outermost end 89 of urethra 4 inorder to ensure proper alignment. For example, if the length of thepatient's urethra is determined to be three cm, the distance between endwall 87 and first and second guide apertures 85 and 86 should be betweenabout 2.5 and about 3.2 cm, most preferably about 2.8 cm. The guideapertures should also be between about 0.25 and about 0.5 cm from distalend 91 of the wing members (FIG. 13). As long as the template ispositioned with end wall 87 abutting the outermost portion of theurethra, the surgeon will be assured that the sutures will be properlyplaced without risk of puncturing the bladder, or urethra.

While the surgeon may employ two fingers beneath wing members 81 and 82to hold the template in the proper position, Applicant has found thatthe provision of arcuate alignment member 88 secured to end wall 87 maybe effectively employed for securing the template in place without theneed for the surgeon to hold the template in any manner. Alignmentmember 88 is preferably positioned parallel to trough 80, with thecenter line of alignment member 88 aligned with the center line oftrough 80. Alignment member 88 may either extend away from trough 80 asshown in FIG. 13, or alternatively may extend away from end wall 87directly along the interior of trough 80 as shown in FIG. 18.

When the embodiment of FIGS. 13-16 is employed, alignment member 88 ispreferably sized so that when the template is manufactured from aresilient material, alignment member 88 may be rigidly snapped aboutFoley catheter 14 as shown in FIG. 20. Thus, the shaft of Foley catheterwill be securely held within alignment member 88, and the surgeon needonly pull outwardly on the Foley catheter while sliding the templateinto the vagina towards the urethra until end wall 87 abuts end 89 ofurethra 2. The ball of the Foley catheter will thus be positioned at theUVJ, and the template will likewise be positioned at the appropriatelocation assuming that a template of the proper size has been selectedbased upon the length of the urethra.

As an alternative to providing various sizes for the template of thepresent invention, a single, larger-sized template may be employedprovided that alignment member 88 is snapped about the shaft of Foleycatheter 14 in the proper location. Thus, instead of abutting end wall87 against end 89 of urethra 2, end wall 87 is instead aligned with theappropriate graduation along the shaft of Foley catheter 14 based uponthe previously-measured length of the urethra. Likewise, end 90 ofalignment member 88 could alternatively be aligned with the appropriategraduation along the shaft of Foley catheter 14 in order to provide theproper placement of the template based upon the length of the patient'surethra.

FIG. 18 depicts yet another alternative embodiment for the template ofthe present invention in which alignment member 88 extends along theinterior of trough 80. In employing this embodiment, alignment member 88is inserted into the urethra along with Foley catheter 13 until end wall87 of the template abuts end 89 of urethra 2. As will be understood,therefor, an appropriately-sized template will ensure proper placementof the sutures.

FIGS. 42-43 depict an alternative, and presently preferred, embodimentfor the surgical template of the present invention. As was the case inthe embodiment of FIGS. 13-16, alignment member 388 extends away fromtrough 380. In this embodiment, alignment member 388 is tubular innature. In addition, the longitudinal axis of alignment member 388 ispositioned slightly above the longitudinal axis of trough 380. Thisspacing provides for more proper alignment of the template. Instead ofrigidly snapping about a Foley catheter, a Foley catheter may merely beslide into alignment member 388 and held in place by friction or othersuitable adhesive means. Preferably, the template of FIGS. 42-43 isprovided to the surgeon with a Foley catheter already extending throughalignment member 388. Preferably, alignment member 388 is sized so as tosnugly hold the Foley catheter therein. In addition, the template isprovided with the Foley catheter located at the desired location.

Wing members 381 and 382 are once again provided, along with first andsecond guide apertures 385 and 386 therein. In order facilitate theinsertion of the tip of a suture retrieval tool through these apertures,grooves 390 are provided on the underside of each wing. Grooves 390extend parallel to the longitudinal axis of trough 380, and preferablyextend between the apertures and the front edge 393 of each wing. Inthis fashion, the tip of the suture retrieval tool may be slid alonggrooves 380 until it reaches the desired aperture. A bevel 391 is alsoprovided on the side of the aperture adjacent grooves 390. Bevel 391permits the retrieving end of the suture retrieval tool to be moved to amore acute angle with respect to the wing member during the retrievalprocess. A similar bevel 391 is provided on the upper surface of eachwing member adjacent each aperture. Bevels 391 on the upper surface ofthe wing members extend from the opposite side of each aperture as thebevels on the under surface of the wing members. This further ensuresthat the retrieving end of the suture retrieval tool can be moved to anacute angle with respect to the wing members.

Finally, the template of the present invention can be manufactured ofany suitable material such as polycarbonate or other FDA-approvedplastic. The template may be readily molded using known technology, andis preferably manufactured as a disposable, single-use item. The drilltamper tool and anchor insertion tools, on the other hand, should bemade from medical-grade stainless steel. The handles, however, may bepolycarbonate or other FDA-approved plastic.

G. Alternative Anchor and Anchor-Insertion Tool

As mentioned previously, and as best shown in FIG. 19, pubic bone 12falls away from the laparoscope at an angle of about 45° to 60°. Thus,it is impossible to create a bore in the pubic bone which extendsperpendicularly from the surface of the bone. Thus, the bore produced inpubic bone 12 extends inwardly at an angle of between about 20° andabout 60°. In other words, as shown in FIG. 23 which is across-sectional view of pubic bone 12, when bore 13 is viewed incross-section as shown, the angle between surface 100 of the pubic boneand bore 13 at X will be between about 20° and about 60°, preferablyabout 45°. During the laparoscopic surgical procedure of the presentinvention, the surgeon may readily modify angle X in order to provide anangle which corresponds to that of the anchor to be described(preferably about 45°). This may be accomplished by inflating ordeflating the abdominal cavity as needed in order to change the angle ofthe laparoscopic channel in relation to the pubic bone. Since interiorsurface 102 of cortical bone 101 is parallel to outer surface 100 ofpubic bone 12, this same angular relationship will exist within theinterior of the bore. When an anchor such as that disclosed in FIGS. 3and 4 is employed, one will immediately recognize that this angularrelationship of surface 102 and bore 13 will only permit the lower barbof the anchor to contact surface 102. Since cancellous (or tribecular)bone 103 offers very little support for the anchor, only the contactbetween the lower most barb of the anchor of FIGS. 3 and 4 and surface102 provides the principle support which prevents the anchor from beingpulled out of the bore.

When anchors of the type shown in FIGS. 3 and 4 are tested for pull-outstrength, they are typically pulled only in the direction of arrow B.After the urethropexy procedure of the present invention isaccomplished, however, any force on the anchor is most often in thedirection of arrow A. As will be readily understood, due to that factthat only the lower barb will be in contact with surface 102, it ispossible for the anchor to be pulled out of the bore due to forcesacting in the direction of arrow A. This results from the fact that theend of the anchor to which the suture is secured is able to pivotdownwardly in the direction of Arrow A since cancellous bone 103 offerslittle support.

In order to overcome the problems of the prior art anchor designs notedabove, the present applicant has developed a new anchor design shown inFIGS. 23-30. The shortcomings of the prior art are overcome by modifyingthe orientation of the wing members or barbs to ensure that the externalends of the wing members (i.e., the portions which contact inner surface102 of the cortical bone) have an angular relationship corresponding tothe angular relationship between bore 13 and surface 102 (to be furtherdescribed in detail below). Thus, as best shown in FIGS. 24 and 25,anchor 139 comprises cylindrical body 140, at least three wing members(barbs 141, 142 and 143), and aperture 150 positioned in tab member 151.Body 140 is similar to that of the prior art designs, however distal end160 may be rounded since it is relatively easy to urge distal end 160into cancellous bone as needed. The conical shape of the prior artdesign, however, will certainly work. Proximal end 161 is preferablyperpendicular to longitudinal axis 162 of body 140 to thereby provide aflat proximal end surface which may cooperate with the newanchor-insertion tool to be described herein. Aperture 150 serves thesame purpose described previously (i.e., a means for attaching a sutureto the anchor), and once again the surfaces and edges of aperture 150should be as smooth as possible to prevent fraying of the suture. Infact, aperture 150 may even be highly polished or even coated to reducefriction.

Tab member 151, as shown in FIGS. 24-26, preferably has a height 163corresponding approximately to the diameter of body 140 and a width 164less than the diameter of body 140. The length 165 of tab member 151should be sufficient for aperture 150 to permit a size 0 suture to bepassed therethrough. It is also preferred that the length of tab member151 extend perpendicularly away from proximal end 161 to facilitatecooperation and mating with the anchor-insertion tool to be described.

As mentioned above, the most significant feature of the anchor shown inFIGS. 23-30 is the arrangement of the wing member or barbs. As is thecase with the prior art anchor design, the barbs may be elasticallyflexed (i.e., have memory) from the normal deployed position (as shownin the figures), to a compressed position. In the deployed position, thebarbs preferably curvilinearly extend radially and axially away frombody 140, as shown. In the compressed position, the barbs aresubstantially straightened to permit insertion of the anchor into a borecreated in bone in the manner of the prior art (see, for example, U.S.Pat. Nos. 5,207,679 and 5,217,486 both of which are herein incorporatedby way of reference). To facilitate compression and insertion, aplurality of channels 170 are provided along the length of body 140. Oneof channels 170 is positioned beneath each of the wing members, and isaligned therewith. Each of the channels is further sized so as to acceptat least a portion of, and preferably the entirety of the correspondingwing member aligned therewith. In this manner, when a wing member iscompressed during the anchor insertion process, the compressed andstraightened wing member will be positioned entirely within channel 170positioned adjacent the wing member.

With the wing members in this compressed state, the diameter of theanchor will be equivalent to that of body 140, thereby permitting theanchor to be inserted into a bore having a diameter only slightlygreater than body 140. As the wing members extend into the bore beyondinterior surface 102 of the cortical bone, the wing members will returnto their deployed position, since the cancellous bone is notsufficiently hard to resist the spring-back of the wing members due totheir inherent elasticity (or memory). As shown in FIG. 23, since thediameter of bore 13 is only slightly greater than body 140, the externalends of the wing members will abut against interior surface 102 therebypreventing removal of the anchor from the bore. For example, externalend 144 of barb 141 is shown in FIG. 23 as resting against interiorsurface 102.

The cross-sectional profile of channels 170 is shown in FIG. 30, whichis a cross-sectional view of the anchor of FIG. 26. As shown in thisview, channels 170 are preferably sufficiently deep to permit an entirewing member to be compressed into the channel. In addition, as shown inFIG. 24, the length of each channel 170 is only sufficiently long tocontain the entire corresponding wing member when the latter iscompressed, Thus, channels 170 may be of different lengths dependingupon the various lengths of the corresponding wing members. End 171 ofchannel 170 (see FIG. 24) may also be angled in relation to thelongitudinal axis 162 as shown in order to correspond with the externalends of the wing members, should these external ends be angled in themanner to be described.

In order to ensure that at least a portion of the external ends of eachwing member contacts interior surface 102 of the cortical bone adjacentbore 13 when bore 13 is positioned non-perpendicularly to outer surface100 of the pubic bone, at least a portion of the external end of eachwing member is aligned along first imaginary plane 175 extending throughbody 140 (see FIG. 25a). In the prior art anchor designs this imaginaryplane is perpendicular to longitudinal axis 162, thereby evenly aligningall of the external ends of the wing members. In the anchor of thepresent invention, however, first imaginary plane 175 extends throughsaid body at an angle to transverse cross-section 176 through body 140,wherein cross-section 176 is perpendicular to longitudinal axis 162. Aswill be understood, angle F of FIG. 25a is preferably substantiallyequivalent to angle X of FIG. 23, thereby ensuring that at least aportion of the external end of each barb will contact interior surface102 of the cortical bone adjacent bore 13. Thus, angle F is preferablybetween about 20° and about 60°, most preferably about 45°. The externalends of the wing members are more preferably tapered as shown so thatthe entirety of each external end will lie along first imaginary plane175. Thus, external ends 144, 145 and 146 of corresponding barbs 141,142, and 148 are aligned along plane 175, thereby adding further supportwhen the anchor is secured within bore 13.

As will be more fully understood later, it is helpful at this point toalso define the top of the anchor by a top-line 166 which extends alongthe surface of body 140 parallel to longitudinal axis 162. Firstimaginary plane 175 intersects top-line 166 at the point of intersectionbetween the surface of body 140 and imaginary plane 175 which is nearestto proximal end 161. In other words, therefore, the barb extending frombody 140 at point nearest to top-line 166 will also have an external endwhich is closest to proximal end 161. The further from top-line 166 thata barb extends from body 140, the further its external end will be fromproximal end 161. The upper portion of body 40 is defined as that halfof body 40 nearest to top-line 166, and the lower portion is thereforethe remainder.

To provide the alignment described above, the wing members may extendfrom the anchor body in a number of fashions. Most preferably, however,each barb should be of a similar length in order to provide similarflexing characteristics for each barb thereby ensuring that the anchorwill be urged straight into the bore. Thus, each wing member preferablyextends from body 140 along a second imaginary plane extending throughbody 140 at an angle to cross-section 176. As will be understood, theangle between this second imaginary plane and cross-section 176 shouldbe approximately equivalent to angle F of FIG. 25a. Alternatively, thewing members may extend from the anchor body at points equidistant fromproximal end 161 (i.e., along a plane extending perpendicular tolongitudinal axis 162). In order to provide the proper alignment for theexternal ends of the barbs, however, the length of the barbs in thisembodiment would necessarily not all be equivalent to one another.

In order to provide proper support during use, various configurationsand numbers of barbs may be employed. Three preferred arrangements areshown in FIGS. 27-29. In the embodiment of FIG. 27, which corresponds tothat of FIGS. 23-26, five barbs are employed. Thus, barbs 141, 142, and143 extend upwardly away from the upper portion of body 40, while barbs148 and 149 extend downwardly away from the lower portion. When theanchor is viewed from the proximal end towards the distal end (FIGS.27-29), it is seen that barb 141 is substantially aligned with thetop-line of body 140. To simplify the description, this will be definedas the 12 o'clock position in terms of a standard clock face. Thus, barb141 is at about 12 o'clock, barb 142 is between about 10 and 11 o'clock,barb 143 is between about 1 and 2 o'clock, barb 149 is between about 4and 5 o'clock, and barb 148 is between about 7 and 8 o'clock. It shouldbe pointed out that whenever an odd number of barbs are employed, it ispreferable that a greater number of barbs extend from the upper portionof the body rather than the lower portion, since further support isneeded in this area.

In the embodiment of FIG. 28, three barbs (152, 153 and 154) areemployed, two of which extend from the upper portion of body 140.Preferably, barb 153 is between about 10 and 11 o'clock, barb 152 isbetween about 1 and 2 o'clock, and barb 154 is at about 6 o'clock. Inthe embodiment of FIG. 29, four barbs (155, 156, 157 and 158) areutilized, two extending upwardly away from the upper portion of body140, and two extending downwardly away from the lower portion of body140. Preferably, barb 155 is between about 10 and 11 o'clock, barb 156is between about 1 and 2 o'clock, barb 157 is between about 4 and 5o'clock, and barb 158 is between about 7 and 8 o'clock. It should benoted that any of a number of alternative configurations are possible,and the three shown are merely exemplary of the simplest and preferredembodiments.

The anchor of the present invention may be made of any of a number ofmaterials, however titanium or titanium alloys are preferred. The anchoris also preferably singularly molded, however the wing members may beformed separately and attached to body 140 during the assembly process.For example, the wing members or barbs may be attached to body 140 inthe manner described in U.S. Pat. Nos. 5,207,679 and 5,217,486. It ispreferred, however, that the barbs comprise wire-like members, and mayeven be formed from titanium or nickel-titanium wires in a knownfashion.

As also discussed previously, aperture 150 of anchor 139 is designed sothat suture 180 may pass therethrough. In this fashion, two suture tailswill extend from aperture 180, and may be used in the manner previouslydescribed to elevate the periurethral tissue at the UVJ, for example. Itis important during such a procedure, however, that the suture beprotected from nicks and other abrasions which would compromise suturestrength. While the proximal end of the anchor shown in FIGS. 23-30 maybe modified to that shown in FIGS. 3-4 so that the anchor-insertion toolof FIGS. 8-10 can be employed therewith, Applicant has developed yetanother anchor-insertion tool which can be employed with the anchordesign shown in FIGS. 23-30. This new anchor-insertion tool not onlyprotects the suture, it also facilitates proper alignment of the anchorwithin the bore and also provides a means for tensioning the suturetails in the manner shown in FIG. 20.

An anchor-insertion tool according to the present invention is shown inFIGS. 31-35, and comprises a rigid elongate member 250 having:

anchor-receiving tip 252

hollow cylindrical intermediate portion 253 having distal end 260adjacent anchor-receiving tip 252, intermediate portion 253 preferablyhaving a diameter greater than the diameter of tip 252

handle 251 attached to intermediate portion 253 at the end oppositeanchor-receiving tip 252

passageway 254 providing communication between the interior ofintermediate portion 253 and the exterior of the tool

Since anchor-receiving tip 252 is also preferably hollow and itsinterior is in communication with the interior of intermediate portion253, an anchor having a suture extending therefrom may be secured on tip252, and the suture (preferably a pair of suture tails) will extendthrough tip 252, through at least intermediate portion 253, and throughpassageway 254. As shown in FIG. 31, passageway 254 is preferablyprovided in handle 251 and terminates on rear face 255 of handle 251.Since passageway 254 is in communication with the interior ofintermediate portion 253, the suture tails may extend along the entireinterior length of the tool, and exit at rear face 255 of handle 251.Thus, as shown in FIG. 32, suture tails 260 and 261 extend from anchor139 held on tip 252, through the entire interior of the tool, and exitat rear face 255. Although the suture tails may exit from the interiorof the tool at various other locations, rear face 255 provides alocation convenient for the surgeon during laparoscopic urethropexy andsimilar procedures. In addition, the sutures are completely enclosedwithin the tool, and thus nicking or fraying cannot occur during theinsertion process. It should be noted that the length of suture tails260 and 261 has been shortened for purposes of clarity.

Anchor-receiving tip 252 should be structured so as to matingly engagethe particular anchor being employed. In addition, as describedpreviously, the diameter of tip 252 should be equivalent to that of theanchor body to facilitate anchor insertion. In the embodiment of FIGS.31-32, tip 252 has a slot 256 extending across the diameter of the tipand at least partially along its length, slot 256 capable or matinglyreceiving tab member 151 of anchor 139. Since it is critical that anchor139 be properly aligned within the bore in the pubic bone, slot 256prevents rotation of the anchor during the anchor insertion process.Slot 256 is preferably sized equivalent to or slightly larger than tabmember 151 of anchor 139, so that tab member 151 may be placed withinslot 256. Tab member 151 may be wedged within slot 256 to hold theanchor on tip 252, or alternatively, end 258 of tip 252 may be securedto proximal end 161 of anchor 139 by means of a releasable adhesive. AnyFDA-approved epoxy or other adhesive may be employed, as long as thebond between end 258 and proximal end 161 may be readily broken afterthe anchor has been seated within the bore merely by pulling theinsertion tool away from the bore. In addition, since the suture tailsare preferably tensioned between the anchor and handle 251 in a mannerto be described, suture tails 260 and 261 will also act to keep tabmember 151 held in place in slot 256.

As best shown in the cross-sectional views of FIGS. 33-34, the wallthickness of tip 252 should be such that suture 180 which extendsthrough aperture 150 of the anchor tab member will not be compressed bythe interior walls of tip 252 when the anchor is in place on tip 252. Inother words, the interior diameter of anchor-receiving tip 252 isgreater than the sum of the width of tab member 151 plus twice thediameter of suture 180. In this manner, suture 180 will be furtherspared from damage during the anchor insertion process.

As will be apparent, in order to properly seat anchor 139,anchor-receiving tip 252 should have a length sufficient to ensure thatall of the barbs of the anchor are inserted past the cortical bone forproper barb deployment. Since it is preferred that proximal end 161 ofanchor 139 be approximately aligned with interior surface 102 of thecortical bone surrounding the bore when the anchor is properly seatedwithin a bore (i.e., external ends of all barbs resting against interiorsurface of cortical bone), it will be apparent that anchor-receiving tip252 should have a length approximately equivalent to, or slightlygreater than the thickness of the cortical bone (between about 5 mm andabout 8 mm). End 260 of intermediate portion 253 not only acts to drivethe anchor into the bore, but also acts as a stop since its diameter ispreferably greater than the anchor body and the bore into which it isbeing inserted. Thus, the proper length for tip 252 will ensure not onlythat the anchor is driven sufficiently deep within the bore to fullydeploy all of the barbs, but also to ensure that the anchor is notdriven too far into the bore. In the latter situation, anchor stabilitymay be compromised, aid the suture may be damaged by the edges of thebore once the surgical procedure has been completed.

In order to facilitate manipulation of the anchor-insertion tool withinthe laparoscope, a plurality of ridges 259 are preferably provided aboutthe circumference of intermediate portion 253. Ridges 259 are preferablypositioned adjacent handle 151, most preferably between about 5 cm andabout 10 cm from the handle. Since the diameter of intermediate portion253 is preferably slightly smaller than the diameter of the laparoscopeto be employed (preferably 7.8 mm and 8.0 mm respectively), ridges 259will assist in controlling the insertion tool during the procedures ofthe present invention. Preferably, ridges 259 are sized so as tocooperate with the standard rubber grommet of a laparoscope.

Handle 252 may be secured to intermediate portion 253 by any of a numberof means, however it is preferable that handle 252 be threadably securedto intermediate portion 253. Thus, corresponding male and female threadsare provided on the handle and the intermediate portion. Once againhandle 251 preferably has curved hand grip surfaces . In thisembodiment, however, handle 251 preferably has dissimilar top and bottomportions 271 and 272, respectively. If anchor 139 is secured to tip 252such that the top-line of the anchor is aligned with top portion 271 ofhandle 251, the surgeon can readily ensure that the anchor will beproperly inserted into the bore. As long as top portion 271 extendsdirectly upwardly during anchor insertion, proper placement will beguaranteed. In order to facilitate alignment, bottom portion 272 ofhandle 251 is preferably significantly heavier than top portion 271.This weight differential will further guarantee alignment, since gravitywill cause the insertion tool to rotate within the laparoscopic channelto the correct position. It should be appreciated, however, that thisalignment means (i.e., and oriented handle) requires that the engagementof handle 251 with intermediate portion 253 be precise. Of course otheralignment means may be provided, such as guide lines, leveling bubbles,and the like.

As mentioned previously, providing tension in the suture tails extendingfrom the anchor will not only help in maintaining the anchor onanchor-receiving tip 252, but will also assist during the sutureretrieval step shown in FIG. 20 (i.e., when the insertion tool has beenpartially removed from the laparoscopic channel). Proper tensioning canbe achieved by means of at least one notch into which the suture tail(s)may be wedged. Preferably, the notch(es) are positioned adjacent saidpassageway so that the suture tails may extend through the passagewaydirectly into the notch(es). Thus notches 280 and 281 are preferablyprovided on rear face 255 of handle 251. In fact, passageway 254preferably exits handle 251 in an elongated diamond-shaped exit 279, andthus notches 280 and 281 may comprise the opposing narrow corners ofexit 279 as shown. When suture tails 260 and 261 leave passageway 254through exit 279, each tail may be wedged within notches 280 and 281,respectively. In this manner, the tails will be tensioned betweennotches 280 and 281 and aperture 150 of the anchor. After the anchor hasbeen inserted into the bore, and as the insertion tool is pulledpartially out of the laparoscopically channel, suture tails 260 and 261will slide within their respective notches, thus maintaining the desiredtension in the suture tails as needed for the suture retrieval step. Tofurther enhance the tensioning of the sutures, passageway 254 may taperfrom intermediate portion 253 towards exit 279, thereby providing anadditional wedging of the suture tails within the final portions ofpassageway 254.

It should be noted that intermediate portion 253 preferably has a lengthof between about 52 cm and about 55 cm to facilitate its use through alaparoscope.

To facilitate a quick and proper anchor insertion process, anchor 139and the anchor-insertion tool of the present invention may be providedto the surgeon in the loaded form of FIG. 32 (with suture attached andwedged for tensioning as shown). The anchor may even be releasablyadhered to the anchor-receiving tip as shown. In this manner, thesurgeon can merely open a sterile surgical kit containing preferably twopre-loaded insertion tools (i.e., anchor 139 engaged withanchor-receiving tip and suture tensioned between anchor and notches onhandle 251). The pre-loaded insertion tools are sufficiently inexpensiveto permit one-time use, or the manufacturer could provide a credit forthe return of used anchor-insertion tools which can be sterilized andre-loaded. The surgical kit for performing laparoscopic urethropexy canalso include a drill tamper tool, a suture retrieval tool, and/or one ormore variously-sized templates (all of which have been describedpreviously). In this fashion, the surgeon will have all of the toolsnecessary for a quick and simple urethropexy within a small sterile kit.

H. Additional Embodiment for Anchor-Insertion Tool

FIGS. 37-41 depict yet another embodiment for the anchor-insertion toolof the present invention. The anchor inserter of FIGS. 37-41 is similarin some respects to that shown in FIGS. 8-10. The principle differencesare the elimination of an intermediate portion, a lengthening of thegrooves, and the positioning of a depression adjacent to the tip. Aswill be understood shortly, these modifications are significant andprovide a considerable advantage over the previously-disclosed design.

The anchor-insertion tool of FIGS. 37-41 comprises an elongate shaft 358having a handle 351 at its proximal end, and an anchor-receiving tip 352at its distal end. Handle 351 may be provided in any of a variety ofshapes, and that shown is merely one possibility. Handle 351 may besecured to shaft 358 by means of threading, glue or other meanswell-known to those skilled in the art. Additionally, handle 351 may beplastic, wherein the remainder of the insertion tool is preferablystainless steel, or other appropriate material.

Anchor-receiving tip 352 is preferably similar to that shown in FIGS.8-10, which in turn is similar to that shown in FIGS. 4-6 of U.S. Pat.No. 5,207,679. Thus, anchor-receiving tip 352 is constructed so as tomatingly receive anchor 9 of FIGS 3-4. Anchor-receiving tip 352 iscylindrical in nature, having a diameter approximately equivalent tobody 40 of anchor 9. In this manner, at least a portion ofanchor-receiving tip 352 may pass into the bore in the pubic bone duringthe anchor insertion process in order to properly seat the anchorcompletely within the bore.

Anchor-receiving tip 352 has a pair of guide tabs 353 extending from theend of anchor-receiving tip 352 on either side thereof. Guide tabs 353are sized and shaped so as to be matingly received within thecorresponding grooves on anchor 9. Anchor-receiving tip 352 also has acylindrical slot 354 aligned with the longitudinal access of tip 352.Cylindrical slot 354 should correspond in size and shape to thecylindrical end of anchor 9 in order to matingly receive the same. Guidetabs 353 and slot 354 preferably apply a compressive force againstanchor 9 in the manner previously described in order to hold anchor 9 ontip 352.

In order to protect the suture tails extending from anchor 9 during theanchor insertion process, a pair of grooves 355 are provided on eitherside of the anchor-insertion tool, and extend from tip 352 at leastpartially along the length of shaft 358 as shown. As compared to theprevious insertion tool design, however, grooves 355 extend along aconsiderable portion of the length of shaft 358. In fact, grooves 355preferably have a length sufficient to insure that the entire length ofeach suture tail is positioned within one of the grooves. In otherwords, when an anchor 9 having a suture extending therefrom ispositioned on anchor-receiving tip 352, a suture tail may be placedentirely within each of grooves 355 with the suture terminating prior toend 402 of groove 355 (FIG. 37).

As best shown in FIG. 40, grooves 355 also preferably taper in themanner described previously. On tip 352, grooves 355 should besufficiently deep to ensure that the suture does not extend above thesurface of the tip. In other words, the sutures will be completelyhidden within the grooves along anchor-receiving tip 352. A distaldepression 359 is provided adjacent tip 352, and grooves 355 preferablybegin to taper outwardly just prior to distal depression 359. Althoughgrooves 355 should be at least as deep (as measured from the surface ofthe shaft 358) as the diameter of the suture, the depth of grooves 355in the region of depression 359 should be such that a portion of thesuture tails will pass through depression 359. In this manner, an O-ringor other retaining band may be secured about depression 359 in order toslidably hold the suture tails within grooves 355. Grooves 355 continueto taper outwardly beyond distal depression 359, and thus, the distanceA between grooves 355 will increase. This provides additional strengthand rigidity to shaft 358.

The anchor-insertion tool of FIGS 37-41 also has one or more depressions360 which extend about the circumference of shaft 358 and intersectgrooves 355 as shown. Depressions 360 are sized to accommodate aretaining band, such as O-rings 361, in order to slidably hold thesuture tails within grooves 355. Thus, depressions 360 should have adepth less than that of grooves 355. Grooves 355 in the region ofdepressions 360 should also be sized such that the O-rings 361 maycompressively and slidably hold the suture tails within grooves 355.Therefore, the difference in depth between grooves 355 and depressions359 and 360 should be less than the diameter of the suture. A suturepositioned within 355 will thus be slidably held between O-rings 361 andgrooves 355. In this manner, the anchor insertion method previouslydescribed can be readily accomplished with the anchor-insertion tool ofFIGS. 37-41, wherein tension is applied to the suture tails when theinsertion is removed from a bore within which the anchor has beensecured.

In the embodiment shown in FIGS. 37-41, the retaining bands, or O-rings361, may be sized such that they act as a grommet during the anchorinsertion process. In other words, after anchor 9 has been loaded uponthe anchor-insertion tool, the tip of the tool is inserted through acannula (such as the operative channel of a laparoscope) in order topresent anchor 9 to the bore into which it will secure. Shaft 358 ispreferably only slightly smaller in diameter than the interior diameterof the cannula, and O-rings 361 may extend above the surface of shaft358. O-rings 361 may therefore act as a grommet within the cannula (e.g.the operative channel of a laparoscope), thereby preventing the escapeof insufflation gas from the interior of the patient. Furthermore,O-rings 361 provide additional stability because of the tight fit withinthe operative channel of the laparoscope.

In the presently preferred embodiment, O-rings 361 preferably are sizedso that they do not extend substantially above the surface of shaft 358.Although such a configuration lessens or eliminates any sealing effectcaused by the O-rings, applicant has found that sealing may also beprovided by the interaction of a seal placed on the end of the cannulawith shaft 358. Such seals are well-known in the art, and are commonlyemployed for this purpose. Additionally, since the suture tails arecarried entirely within grooves 355, a relatively tight fit betweenshaft 358 and the cannula may be maintained, thereby further lesseningthe escape of insufflation gas. Furthermore, end 402 of grooves 355 islocated well ahead of handle 351, preferably at a distance sufficient toensure that during the normal insertion process grooves 355 (and hencethe suture tails present therein) will remain entirely within thepatient or the cannula. In this fashion, grooves 355 will not permitinsufflation gas to escape from the interior of the patient.

Often it is difficult for a surgeon to thread sutures into needles andthe like while performing surgical procedures, particularly because ofthe difficulties caused by surgical gloves. In order to alleviate suchproblems, applicants have also developed a unique method for threadingthe sutures onto the anchor-insertion tool. As best shown in FIG. 41, apair of suture threaders 400 are pre-loaded on the anchor-insertiontool. Similar suture threaders are employed for threading surgicalneedles and the like. In the present case, each suture threader 400comprises a length of wire which is bent at its middle to form a loop401. The opposite ends of the threader are then secured to a pull tab(or handle) 357. In the present case, both suture threaders arepreferably connected to a single pull tab 357 as shown. Each suturethreader is inserted into one of the grooves 355 as shown, with its loop401 extending beyond and adjacent tip 352. At its opposite end, eachthreader preferably extends beyond end 402 of grooves 355 such that pulltab 357 may be readily accessed. O-rings 361 are then secured about theanchor-insertion tool within depressions 359 and 360. This results ineach suture threader being slidably held within one of grooves 355beneath O-rings 361 as shown.

In order to utilize the suture threaders, an anchor is first secured ontop tip 352. Since tip 352 will orient the anchor in a pre-determinedmanner, loops 401 of the threaders as shown in FIG. 41 will align withaperture 43 on anchor 9. In this manner, the surgeon or other medicalpersonnel may simply thread the suture straight through one of loops401, aperture 43 on anchor 9, and thereafter through the second loop401. Once threaded, the suture is centered within aperture 43, and thenpull tab 357 is grasped. As pull tab 357 is retracted in the directionof handle 351 away from grooves 355, the suture tails will be pulledinto grooves 355 by loops 401. As the surgeon continues to retract pulltab 357, the sutures are threaded into grooves 355 beneath O-rings 361,thereby loading the suture onto the device in the proper manner. Thus,the suture threaders provide a convenient way for the surgeon to preparethe anchor-insertion tool for the surgical procedures of the presentinvention.

As discussed previously, after anchor 9 has been secured within a borein the pubic bone, the anchor-insertion tool can be retracted away fromthe anchor by means of handle 351. When the insertion tool is retractedin this way, the suture tails will slide between O-rings 361 and grooves355 such that the suture tails will extend between the anchor and thetool after this retraction step. The tool should not be completelywithdrawn at this point, however, since the suture tails should bepermitted to extend between the tool and the anchor in order to allowsuture retrieval as shown in FIG. 20. It is also preferred that thesuture tails and grooves 355 be sufficiently long so that the insertiontool can be retracted as shown in FIG. 20 while ensuring that the sutureremains beneath all of the O-rings 361. In this manner, the suture tailswill be controlled and the barbs of the anchor will be deployed by meansof the tensioning of the suture tails. In addition, this insures thatthe O-rings 361 will remain within the cannula or operative channel ofthe laparoscope for sealing purposes, if any. Finally, shaft 356 alsoterminates in distal end 358 which is shown as being tapered. Thetapering of distal end 356 provides improved laparoscopic vision duringthe insertion process. In addition, tapered distal end 356 acts as astop during the anchor insertion process, thereby insuring that theanchor is inserted to the proper depth.

In the embodiment shown in FIGS. 36-38, anchor-receiving tip 352 onceagain preferably has a length sufficient to insure proper anchor depth.Since anchor-receiving tip 352 preferably has a diameter equivalent tothat of anchor 9, which in turn is only slightly smaller than the borein the pubic bone, distal end 356 acts as a stop during the insertionprocess. Therefore, the length of anchor-receiving tip 352 should beapproximately equal to the depth of the bore minus the length of theanchor. Shaft 358 should be of a length sufficient to permit the tool tobe effectively employed through a laparoscope. Thus, shaft 358 has alength of between about about 45 and about 60 cm, preferably betweenabout 50 and about 52 cm. The length of the grooves should be sufficientensure that the entire length of both suture tails can be positionedentirely within one of the grooves, while also ensuring that the groovesremain either within the abdominal cavity or within the operativechannel of the laparoscope when the insertion tool is partiallyretracted as shown in FIG. 20. This ensure that insulflation gas cannotescape through the grooves. Preferably, the grooves between about 25 cmand about 30 cm from the tip. While it is preferred that a at least onedepression be positioned adjacent the tip, any number of additionaldepressions may be provided anywhere along the length of the shaft. Twoor three additional depressions 360 are preferred as shown in theaccompanying drawings.

The foregoing description of preferred embodiments is by no meansexhaustive of the variations of the present invention which arepossible, and has thus been presented only for purposes of illustrationand description. These modifications and variations will be apparent tothose skilled in the art in light of the teachings of the foregoingdescription, and these modifications and variations are well within thescope of the present invention. For example, the anchorinsertion toolsof the present invention may be used with any of a variety of anchortypes, provided that the anchor-receiving tip is modified accordingly.For example, the anchor-receiving tip of the tool shown in FIGS. 36-38herein may be modified to correspond with that shown in U.S. Pat. No.5,100,417, thereby permitting the use of the anchor of this patent withthe insertion tool of the present invention. Similar modifications toanchor-receiving tip 352 would enable one to use various other types ofanchors, and such modifications are well-within the scope of the presentinvention. Thus, it is intended that the scope of the present inventionbe defined by the claims appended hereto, and not by the specificembodiments shown in the drawings.

What we claim is:
 1. A method for retrieving a portion of a suture fromwithin a patient's body, comprising:(a) providing a suture retrieverhaving a retrieving end; (b) inserting said retrieving end into thepatient's body through the patient's vagina; and (c) pulling a portionof said suture into the patient's vagina with the retrieving end of saidsuture retriever.
 2. The method of claim 1, wherein said retrieving endis vaginally inserted into the patient's body through the periurethraltissue, and wherein said portion of said suture is pulled into thevagina through the periurethral tissue.
 3. The method of claim 1,wherein said retrieving end has a sharp tip, such that said step ofvaginally inserting said retrieving end into the patient's bodycomprises urging said sharp tip through the vaginal mucosa andperiurethral fascia.
 4. The method of claim 1, wherein said suture ispositioned within the space of Retzius and extends from a bone anchorsecured to the pubic bone of the patient.
 5. The method of claim 3,wherein:said suture retriever further comprises a handle; and saidretrieving end comprises a shaft, with said sharp tip located at one endthereof;and wherein said handle and said shaft are configured such thatwhen said retrieving end is vaginally inserted into the patient's bodyto retrieve said suture, at least a portion of said handle remainssubstantially outside of the patient's vagina.
 6. The method of claim 3,wherein:said suture retriever further comprises a handle and a midshaftpositioned between said retrieving end and said handle; said retrievingend comprises a shaft, with said sharp tip located at one end thereof;said midshaft and said shaft of said retrieving end are secured to oneanother in an angular relationship; and said handle and said midshaftare secured to one another in an angular relationship;such that whensaid retrieving end is vaginally inserted into the patient's body toretrieve said suture, at least a portion of said handle remainssubstantially outside of the patient's vagina.
 7. A method of passingthe tail of a suture from the interior of the patient's body into thepatient's vagina, comprising:(a) providing a suture retriever having aretrieving end; (b) inserting said retrieving end of the sutureretriever into the vagina and thereafter through the vaginal mucosa andperiurethral fascia into the patient's body; (c) snaring said suturetail with said retrieving end; and (d) withdrawing said retrieving endinto the vagina along with the suture tail.
 8. The method of claim 7,wherein a portion of said suture retriever remains outside of thepatient's vagina.